Navigating ISO Cleanroom Standards: Understanding Filters for Each Level

Cleanrooms are essential in industries where particulate contamination can significantly impact product quality and safety, such as in pharmaceuticals, biotechnology, and electronics manufacturing. The International Organization for Standardization (ISO) provides a classification system for cleanrooms based on the number of particles allowed per cubic meter of air. Each ISO class has specific requirements for air filtration to maintain the desired level of cleanliness. Let's explore the different ISO levels of cleanrooms and the filters required or recommended for each.


ISO 1 to ISO 3: Ultra-Clean Environments

ISO 1: The cleanest level, allowing no more than 10 particles larger than 0.1 microns per cubic meter. Requires multiple stages of filtration, including HEPA and ULPA (Ultra Low Penetration Air) filters with efficiencies of 99.999% at 0.1 to 0.2 microns.

ISO 2 and ISO 3: Slightly less stringent, but still require ULPA filters to maintain particle counts of 100 and 1,000 at 0.1 microns, respectively.

ISO 4 to ISO 6: High Cleanliness Requirements

ISO 4: Allows up to 10,000 particles at 0.1 microns. Typically requires HEPA filters with an efficiency of 99.99% at 0.3 microns, along with pre-filters to extend the life of the primary filters.

ISO 5 and ISO 6: Permit 100,000 and 1,000,000 particles at 0.1 microns, respectively. HEPA filters are still the standard, with ISO 5 often used in pharmaceutical compounding and ISO 6 in less critical manufacturing areas.

ISO 7 to ISO 9: Controlled Environments

ISO 7: Allows up to 10 million particles at 0.1 microns. HEPA filters are recommended, with a focus on maintaining proper air changes per hour (ACH) to dilute and remove contaminants.

ISO 8 and ISO 9: Permit up to 100 million and 1 billion particles at 0.1 microns, respectively. While HEPA filters are still used, the emphasis shifts towards maintaining cleanliness through regular cleaning and monitoring.


Meeting Cleanroom Standards with Frankal Innovations

Maintaining the required ISO cleanroom standards is crucial for product quality and safety. Frankal Innovations offers a comprehensive range of filtration solutions tailored to meet the specific needs of each ISO class. Whether you require ULPA filters for an ISO 1 cleanroom or HEPA filters for an ISO 7 environment, Frankal Innovations has the expertise and products to ensure your cleanroom operates at peak efficiency.

In addition to providing high-quality filters, Frankal Innovations can assist with filter selection, installation, and maintenance, helping to ensure your cleanroom maintains its required ISO classification. Trust Frankal Innovations to be your partner in achieving and maintaining the optimal cleanroom environment for your critical processes.